BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2490382 · Received March 13, 2012

    Report

    Report Number
    2122870-2012-00684
    Event Type
    Malfunction
    Date Received
    March 13, 2012
    Date of Event
    February 15, 2012
    Report Date
    February 22, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LTJ
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. THE CUSTOMER SENT IN PATIENT SAMPLES TO BECKMAN COULTER INC FOR INVESTIGATIVE TESTING, HOWEVER, RESULTS OF THE INVESTIGATIVE TESTING HAVE NOT BEEN AVAILABLE TO DATE. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE. ASSOCIATED MDRS: 2122870-2012-00682, 2122870-2012-00684, 2122870-2012-00755, 2122870-2012-00686.

    Additional Manufacturer Narrative · 1

    INVOLVED PATIENT SAMPLES WERE RETURNED TO BECKMAN COULTER FOR ASSESSMENT. TESTING AT THE BECKMAN COULTER CUSTOMER PRODUCT LINE SUPPORT LABORATORY WITH INTERFERENCE ELIMINATING PROTEINS CONFIRMED THE EXISTENCE OF A PATIENT SOURCE INTERFERENT FOR THE SAMPLES RECEIVED FROM THE CUSTOMER. PER BECKMAN COULTER INC. ACCESS HYBRITECH FREE PSA ASSAY INSTRUCTIONS FOR USE 2011 BECKMAN COULTER, INC. (B)(4): FOR ASSAYS EMPLOYING ANTIBODIES, THE POSSIBILITY EXISTS FOR INTERFERENCE BY HETEROPHILE ANTIBODIES IN THE PATIENT SAMPLE. PATIENTS WHO HAVE BEEN REGULARLY EXPOSED TO ANIMALS OR HAVE RECEIVED IMMUNOTHERAPY OR DIAGNOSTIC PROCEDURES UTILIZING IMMUNOGLOBULINS OR IMMUNOGLOBULIN FRAGMENTS MAY PRODUCE ANTIBODIES, E.G. HAMA, THAT INTERFERE WITH IMMUNOASSAYS. ADDITIONALLY, OTHER HETEROPHILE ANTIBODIES SUCH AS HUMAN ANTI-GOAT ANTIBODIES MAY BE PRESENT IN PATIENT SAMPLES. SUCH INTERFERING ANTIBODIES MAY CAUSE ERRONEOUS RESULTS. CAREFULLY EVALUATE THE RESULTS OF PATIENTS SUSPECTED OF HAVING THESE ANTIBODIES. THE CAUSE OF THE ERRONEOUS RESULTS INVOLVED IN THIS EVENT WAS PATIENT SAMPLE INTERFERENCE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HIGHER THAN EXPECTED FREE PROSTATE SPECIFIC ANTIGEN (FPSA) INITIAL RESULTS WERE GENERATED FROM THREE UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEMS FOR ONE PATIENT SAMPLE OVER MULTIPLE DAYS. THIS REPORT REPRESENTS THE ERRONEOUS FREE PSA RESULTS GENERATED FROM THE UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM WITH SERIAL NUMBER (B)(4) ON (B)(6) 2012. THE FPSA RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND WAS QUESTIONED AS IT DID NOT CORRELATE WITH THE CORRESPONDING TOTAL HYBRITECH PSA RESULT FOR THE SAMPLE. THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE SAMPLE WAS A SERUM SAMPLE COLLECTED IN A TERUMO VENOJECT II WITH PROCOAGULANT FILM. THERE WERE NO PROBLEMS WITH THE SAMPLE DRAW. FPSA QUALITY CONTROL RESULTS WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES ON THE DATE OF THE EVENT. ADDITIONAL SYSTEM INFORMATION AND SAMPLE COLLECTION/HANDLING INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. PATIENT SPECIFIC INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY LTJ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS HYBRITECH FREE PSA